Venous access device

ABSTRACT

A venous access device includes a hub and a bifurcated cannula. The hub includes a bifurcated connecting arm, a blood sampling arm connected to the bifurcated connecting arm, a fluid transfer arm connected to the bifurcated connecting arm, a blood sampling channel and a fluid transfer channel. The blood sampling channel passes through the blood sampling arm and the bifurcated connecting arm. The fluid transfer channel passes through the fluid transfer arm and the bifurcated connecting arm. The bifurcated cannula is coupled to the bifurcated connecting arm and includes a blood sampling lumen having a blood sampling port, a fluid transfer lumen having a fluid transfer port, and a dividing member separating the blood sampling lumen from the fluid transfer lumen. The blood sampling port is 2 mm to 20 mm proximal from the fluid transfer port. The blood sampling channel is fluidly connected to the blood sampling lumen, and the fluid transfer channel is fluidly connected to the fluid transfer lumen.

BACKGROUND

According to the Centers for Disease Control and Prevention (CDC), 35.1million people are admitted to non-Federal, short-stay hospitals in theUnited States annually. The vast majority of those patients receiveintravenous (IV) therapy to deliver or withdraw fluids such asmedications, electrolytes and blood. IV therapy requires the insertionof a venous access device, such as a peripheral venous catheter or acentral venous catheter, into a vein. IV therapy is frequently usedbecause it is the fastest way to deliver fluids systemically and becausethe bioavailability of medicines delivered intravenously is 100%.

A venous access device includes a cannula or catheter inserted throughthe skin and into a vein. The cannula may be introduced to the veinusing a metal trocar or a hypodermic needle to pierce the skin and vein.Once the cannula is advanced to the appropriate location within thevein, the trocar or needle may be removed. The external portion of thecannula may be connected to a syringe or an infusion line, or may becapped or sealed when not in use. A peripheral venous access device isinserted into a peripheral vein, often in the arm or hand, while acentral venous access device is placed into a central vein such as thevena cava, internal jugular vein, subclavian vein or femoral vein.Peripheral venous catheters are the most commonly used vascular accessdevices in medicine.

Some endocrinologists have proposed that all hospitalized patientsundergo blood glucose (blood sugar) monitoring since hyperglycemia isoften asymptomatic and undiagnosed. Certain hospitalized patients, suchas people with diabetes and patients recovering from cardiac surgery,require frequent testing of their blood. The American Association ofClinical Endocrinologists and the American Diabetes Associationrecommend that hospitalized patients with diabetes have their bloodglucose tested every 4 to 6 hours. Furthermore, it is recommended thathospitalized patients receiving intravenous insulin undergo even morefrequent blood glucose testing, ranging from every 30 minutes to every 2hours. A blood sample is typically obtained by a venous blood draw or,for smaller samples such as those used in blood glucose monitoring, afinger prick using a lancet.

Blood sampling has a number of inherent risks. Any skin puncture,whether venous or by finger prick, is painful for a patient. Adverseeffects include fainting, loss of consciousness, extravasation, nervedamage, formation of hematomas (bruising) and infiltration (blown vein).Every time that a patient's skin is broken there is a possibility ofinfection. Blood sampling also carries risks for the medicalprofessional obtaining the sample; handling sharp objects such ashypodermic needles and lancets may result in accidental needle sticks.Medical professionals must be especially careful to avoid needle stickswith used hypodermic needles or lancets to avoid exposure to blood-bornepathogens. Furthermore, the disposable needles and lancets used in bloodsampling create a large amount of sharps waste, which must be carefullydisposed of. All of these risks are magnified and increased when thefrequency of blood sampling is increased.

Frequent blood sampling is expensive due to the large amount of suppliesinvolved. A single hospitalized patient may require 4 to 48 lancets ordisposable syringes per day. CDC statistics show that the averagehospital stay is 4.8 days, which means that the average diabetic patientwill require 20 to 231 lancets while hospitalized. Although bloodsampling supplies are inexpensive individually, they represent aconsiderable expense for hospitals in the aggregate. These costs areultimately borne by patients and insurers.

A significant problem presented by frequent blood sampling is also theneed for overnight sampling. Hospitalized patients that require frequentblood testing must be woken up multiple times throughout the night sothat medical professionals may obtain necessary periodic blood samples.These nighttime interruptions can impair a patient's ability to achievea deep, restorative sleep. Sleep interruption has been shown to slow thehealing process and result in longer hospital stays. This is especiallyproblematic for diabetic patients since slower than normal healing is aknown complication of diabetes.

One apparent solution to avoid waking a hospitalized patient formultiple venous blood draws or finger pricks is to obtain blood samplesfrom a venous access device that has already been inserted. However,this practice is strongly disfavored. The World Health Organization(WHO) guidelines state that it is acceptable, but not ideal, to drawblood specimens when first inserting a venous access device (WHOGuidelines on Drawing Blood: Best Practices in Phlebotomy, 2010). TheWHO guidelines advise against obtaining blood samples from venous accessdevices that have been used for intravenous therapy because hemolysis,contamination and the presence of intravenous fluid and medication canalter the blood sample results. Blood samples taken from central venousaccess devices also carry a risk of inaccurate laboratory results andcontamination.

SUMMARY

In a first aspect, the invention is a venous access device including ahub and a bifurcated cannula. The hub includes a bifurcated connectingarm, a blood sampling arm connected to the bifurcated connecting arm, afluid transfer arm connected to the bifurcated connecting arm, a bloodsampling channel and a fluid transfer channel. The blood samplingchannel passes through the blood sampling arm and the bifurcatedconnecting arm. The fluid transfer channel passes through the fluidtransfer arm and the bifurcated connecting arm. The bifurcated cannulais coupled to the bifurcated connecting arm and includes a bloodsampling lumen having a blood sampling port, a fluid transfer lumenhaving a fluid transfer port, and a dividing member separating the bloodsampling lumen from the fluid transfer lumen. The blood sampling port is2 mm to 20 mm proximal from the fluid transfer port. The blood samplingchannel is fluidly connected to the blood sampling lumen, and the fluidtransfer channel is fluidly connected to the fluid transfer lumen.

In a second aspect, the invention is a method of performing a bloodtest, including obtaining a blood sample from a patient through a venousaccess device, and performing the blood test with the blood sampleobtained from the patient through the venous access device.

In a third aspect, the invention is a kit, including a needle and avenous access device. The needle and the venous access device aresterile.

DEFINITIONS

The terms “cannula” and “catheter” are used interchangeably and refer toany tube that is inserted into the body for the purpose of transferringfluids.

The terms “lumen” and “channel” both refer to passages through astructure. Different elements of the venous access device are referredto as lumens or channels for clarity, but both terms have the samemeaning.

The term “diabetes” means a metabolic disease characterized by highblood glucose levels (hyperglycemia) over a prolonged period of time. Asused herein, “diabetes” includes diabetes mellitus type I, diabetesmellitus type II and gestational diabetes.

The terms “distal” and “proximal” are used to describe a locationrelative to the hub of the venous access device. For example, theproximal end of the bifurcated cannula is coupled to the hub, and thedistal end of the bifurcated cannula is inserted into a patient's vein.

All percentages (%) are weight/weight percentages, unless statedotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention can be better understood with reference to the followingdrawings and description.

FIG. 1 illustrates a venous access device.

FIG. 2 illustrates a hub.

FIG. 3 illustrates a sectioned partial view of a hub coupled to abifurcated cannula.

FIG. 4 illustrates a bifurcated cannula.

FIG. 5A illustrates a partial view of a bifurcated cannula and a needlein an over-the-needle configuration.

FIG. 5B illustrates a partial view of a bifurcated cannula and a needlein a through-the-needle configuration.

FIG. 6 illustrates a kit for cannulating a patient.

FIG. 7 illustrates an alternative configuration of a kit for cannulatinga patient.

FIG. 8 illustrates a method of performing a blood test.

The drawings are not to scale. Particularly, the bifurcated cannulaappears much larger in the figures than it actually is in the device.

DETAILED DESCRIPTION

There is a need for a blood sampling device that eliminates repeatedpatient disturbances and painful needle sticks. A venous access devicecapable of both fluid delivery and blood sampling would significantlyreduce many of the adverse issues presented by frequent blood sampling.It would also represent a major cost savings for hospitals. However, avenous blood sampling device must avoid the contamination risks andinaccurate results described in the WHO guidelines.

The present invention is a venous access device that is capable of bothtransferring fluids and sampling blood intravenously from the samedevice simultaneously. Applicants have created a venous access deviceincluding a bifurcated cannula containing a blood sampling port 2 to 20millimeters proximal from a fluid transfer port that allows bloodsamples to be obtained that are not affected by the fluids beingtransferred. This design eliminates repeated blood draws or fingerpricks that have typically been necessary for frequent blood sampling ofhospitalized patients. The venous access device reduces patient pain andthe potential for adverse effects by decreasing the number of skinpunctures. The elimination of sleep interruptions common withtraditional overnight blood sampling accelerates patient recovery times.The venous access device significantly reduces costs for hospitals,patients, and insurers by reducing the duration of hospital stays and byminimizing the amount of blood sampling equipment used.

FIG. 1 illustrates a venous access device 100. The venous access deviceincludes a hub 110 and a bifurcated cannula 120. A blood samplingchannel 130 and a fluid transfer channel 140 are present in the hub. Thebifurcated cannula is coupled to the hub, and includes a blood samplinglumen 150 and a fluid transfer lumen 160. The blood sampling channel andthe fluid transfer channel are in fluid connection with the bloodsampling lumen and the fluid transfer lumen, respectively. The venousaccess device may be inserted into a vein in the direction of blood flowin the vein. For example, if the venous access device is inserted into apatient's forearm or hand, the bifurcated cannula will point towards thepatient's shoulder and the hub will point towards the patient's fingers.This placement ensures that any fluids being transferred into the veinare carried with the flow of blood towards the heart and that any bloodbeing removed is upstream (farther away from the heart) of the fluidtransfer site. Preferably, the venous access device is sterile.

FIG. 2 illustrates a hub 200. The hub includes a bifurcated connectingarm 210, a blood sampling arm 220 and a fluid transfer arm 230. Theblood sampling arm and the fluid transfer arm are both connected to theconnecting arm. A blood sampling channel 240 passes through the bloodsampling arm and the bifurcated connecting arm. A fluid transfer channel250 passes through the fluid transfer arm and the bifurcated connectingarm. The hub may be composed of any rigid, durable material. Preferably,the hub is composed of a rigid polymer, but non-rigid polymers orelastomers may also be used. Examples of suitable materials for the hubinclude polypropylenes, polyethylenes, polycarbonates and polyamides(such as nylon). The hub may be formed by any suitable manufacturingprocess, such as injection molding or extruding. The bifurcatedconnecting arm, the blood sampling arm, and the fluid transfer arm maybe three discrete parts, or the hub may be a single monolithiccomponent.

The blood sampling arm and the fluid transfer arm may optionally includefittings that allow additional components to connect to the arms.Suitable fittings include Luer fittings, quick connect fittings (alsoknown as quick disconnect couplings), adaptors, plugs, caps, valves andcheck valves. A preferred fitting is a Luer lock fitting. FIG. 2 shows afirst fitting 225 coupled to the blood sampling arm 220, and a secondfitting 235 coupled to the fluid transfer arm 230. Alternatively, thefitting may part of the blood sampling arm or the fluid transfer arm,forming a monolithic arm and fitting component.

The blood sampling channel and the fluid transfer channel may optionallyinclude one or more one-way valves to prevent the unintended flow ofblood and/or fluids through the channels. The one-way valves areseparate from any valves present as fittings attached to the bloodsampling arm and/or the fluid transfer arm. FIG. 2 shows a first one-wayvalve 245 in the blood transfer channel 240, and a second one-way valve255 in the fluid transfer channel 250.

FIG. 3 illustrates a sectioned partial view of a hub 310 coupled to abifurcated cannula 320. The hub may be coupled to the bifurcated cannulausing an adhesive or using a coupling member, such as a fitting or anadaptor that connects to both the hub and the bifurcated cannula. Ablood sampling channel 330 and a fluid transfer channel 340 are presentin the hub. A blood sampling lumen 350 and a fluid transfer lumen 360are present in the bifurcated cannula and are separated by a dividingmember 370. The blood sampling channel is fluidly connected to the bloodsampling lumen, and the fluid transfer channel is fluidly connected tothe fluid transfer lumen. The separate lumens and channels allow bloodto be sampled and fluids to be transferred through the venous accessdevice without mixing, which ensures the blood being sampled is notaffected by the fluid being transferred.

FIG. 4 illustrates a bifurcated cannula 400. The bifurcated cannulaincludes a blood sampling lumen 410, a fluid transfer lumen 420 and aninternal dividing member 430 separating the blood sampling lumen fromthe fluid transfer lumen. The fluid transfer lumen has a fluid transferport 440 and the blood sampling lumen has a blood sampling port 450. Theblood sampling port and the fluid transfer port are openings thatprovide the blood sampling lumen and the fluid transfer lumen,respectively, access to a patient's venous blood. The distal end 460 ofthe bifurcated cannula is inserted into a patient's vein while theproximal end 470 of the bifurcated cannula remains outside of thepatient's vein so that it may be coupled to a hub (not shown).

The blood sampling lumen and the fluid transfer lumen are two distinctspaces within the bifurcated cannula, as illustrated in FIG. 4. Theblood sampling lumen may be defined by the dividing member and a portionof the inner surface of the cannula, as shown in FIG. 4. In thisconfiguration, the dividing member tapers from the distal end of thecannula to form the blood sampling lumen within the cannula. Thedividing member ensures that the blood sampling lumen is separated fromthe fluid transfer lumen and that blood and fluids are not mixed withinthe cannula. Alternatively, the blood sampling lumen may be concentricwith the fluid transfer lumen.

The blood sampling port is located 2 to 20 mm proximal from the fluidtransfer port, preferably 5 to 16 mm proximal from the fluid transferport, more preferably 8 to 12 mm proximal from the fluid transfer port.Suitable distances between the blood sampling port and the fluidtransfer port include 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,16, 17, 18, 19 and 20 mm. Greater distances are also possible. The bloodsampling port should be located sufficiently apart from the fluidtransfer port to obtain a blood sample that does not contain any fluidentering the patient through the fluid transfer lumen. When thebifurcated cannula is inserted into a vein, the blood sampling port willbe upstream (farther away from the heart) of the fluid transfer port inrelation to the flow of blood through the vein.

The bifurcated cannula may be rigid or flexible. The bifurcated cannulashould have some flexibility but must be sufficiently rigid forinsertion into a vein. The bifurcated cannula may be composed of anysuitable material that is capable of blood and fluid transport and canwithstand the venous pressure encountered in healthy patients and thosewith vascular disease or poor vascular health, typically 5 to 22 mm Hg.Suitable materials for the bifurcated cannula include polyurethanes,polyamides (such as nylon), polyether block amides (PEBA, such asPEBAX®), polytetrafluoroethylenes (PTFE) and BD VIALON® biomaterial(Becton, Dickinson and Company). The bifurcated cannula may be formed byextruding or injection molding. The bifurcated cannula may be providedin a variety of gauge sizes to accommodate adult and pediatric patients.For example, a normal adult patient may receive a 17, 18 or 19 gaugecannula, while a pediatric patient may receive a 20, 21, 22, 23 or 24gauge cannula. The cannula may be 5 to 100 mm long, preferably 10 to 75mm long, more preferably 20 to 50 mm long.

The venous access device may optionally include a needle for penetratingthe skin and the vein to insert the cannula. FIG. 5A illustrates apartial view of a bifurcated cannula 500 and a needle 510 in anover-the-needle configuration. FIG. 5B illustrates a partial view of abifurcated cannula 520 and a needle 530 in a through-the-needleconfiguration. The needle is composed of metal, preferably stainlesssteel. The needle may optionally include a cap. The needle may beretractable or non-retractable. Preferably, the needle is sterile.

In an alternative configuration, the hub and the bifurcated cannula maybe a monolithic component. A monolithic hub-cannula may be formed byinjection molding, extruding or additive manufacturing (3-D printing).The same material may be used for the hub and the bifurcated cannula ifit has suitable physical properties for each component. For example,nylon may be an appropriate material for use in producing a monolithichub-cannula by additive manufacturing. The monolithic hub-cannula mayinclude a retractable needle that retracts into the hub after thecannula has been inserted into a vein.

FIG. 6 illustrates a kit 600 for cannulating a patient. The kit ishoused in a container 610. The kit contains a needle 620 and a venousaccess device 630. The kit optionally includes a tourniquet 640 in theform of an elastic strip. An optional antiseptic swab 650 may also beincluded in the kit. Optional printed instructions 660 describe how toinsert and use the venous access device. An optional dressing 670 may beincluded in the kit. The kit optionally includes flushing materials 680in the form of a pre-filled syringe. The needle may optionally be aretractable needle. Preferably, the needle, the venous access device andany additional kit components are sterile.

The kit may optionally include a topical antiseptic. For example, theantiseptic may be delivered in a swab, wipe, gel, ointment or spray. Theantiseptic may be used to clean the venous access site prior toinserting the needle and cannula. Preferred topical antiseptics includechlorhexidine and alcohol.

The kit may optionally include a tourniquet. The tourniquet may be usedto temporarily restrict blood flow near the venous access site and makethe vein easier to locate. The tourniquet may be, for example, anelastic strip, an elastic tube, a cloth or a bandage.

The kit may optionally include items for covering the venous access siteafter the cannula has been inserted into a vein. For example, the kitmay contain a transparent dressing, tape or an adhesive bandage.

The kit may optionally include materials for flushing the venous accessdevice after insertion. The kit may include a pre-filled syringecontaining a flushing solution, or an empty syringe and a vial orampoule of flushing solution. A preferred flushing solution is saline. Asaline flush may be performed using 5 mL of saline.

The kit may optionally include instructions for use. The instructionsmay be provided as printed instructions or in electronic format, such ason a universal serial bus (USB) drive, on a secure digital (SD) card, orhosted over the internet and accessible through a quick response (QR)code.

The kit may optionally include a container for housing the kitingredients. The container protects the needle, venous access device andany other components from damage. The container may be formed of arigid, durable material such as plastic.

Kits may be provided that contain different sized cannulae for differentintended patients. For example, a kit for use in adult patients maycontain a 17, 18 or 19 gauge cannula. Similarly, a kit for use inpediatric patients may contain a 20, 21, 22, 23 or 24 gauge cannula.

FIG. 7 illustrates an alternative configuration of a kit 700 forcannulating a patient. The kit is housed in a container 710. The kitcontains a needle 720 that has been pre-threaded through a venous accessdevice 730. The needle includes a cap 740. This configuration isparticularly useful when the hub and the bifurcated cannula are a singlemonolithic component.

Blood samples obtained by the venous access device may be used toperform a number of blood tests. For example, blood samples may be usedin a blood glucose test, an amylase test, an antinuclear antibody (ANA)test, a partial thromboplastin time (PTT) test, an internationalnormalized ration (INR) test, a prothrombin time (PT) test, a hemoglobinA1C test, a basic metabolite panel (BMP), a complete blood count (CBC)test, a comprehensive metabolic panel (CMP), an electrolyte test, anerythrocyte sedimentation rate (ESR) test, a flu test, a human chorionicgondadotropin (hCG) test, an HIV antibody test, a lipid profile, a liverpanel, a microalbumin test, a prostate-specific antigen (PSA) test or athyroid-stimulating hormone (TSH) test.

A blood sample may be obtained by attaching a device to the bloodsampling arm and applying a negative pressure to the blood samplingchannel to draw blood through the blood sampling channel. For example, amedical professional may manually obtain a blood sample withoutdisturbing the patient by attaching a syringe to the blood sampling armand withdrawing the plunger of the syringe. Alternatively, blood samplesmay be obtained automatically using an automated sampling device. Such adevice may include, for example, a blood testing instrument containing apump in fluid connection with the blood testing channel. The bloodtesting instrument may be programmable and capable of obtaining bloodsamples according to a regular schedule. The venous access device iscapable of simultaneous fluid delivery and blood sampling.

FIG. 8 illustrates a method of performing a blood test at 800. First, ablood sample is obtained from a patient through a venous access deviceat 810. Next, a blood test is performed with the blood sample obtainedfrom the patient through the venous access device 820.

In addition to use in humans, the venous access device may also be usedin animals. An appropriately-sized venous access device may be used forfluid transport and blood sampling in an animal in need of intravenoustherapy and blood monitoring. The venous access device may be used inthe treatment of companion animals, such as dogs and cats, or livestock,such as horses.

EXAMPLES Example 1—Bench Test in Artificial Hand

An artificial hand including a central tube was chosen to simulate ahuman hand and the cephalic vein. The central tube was connected to apump and contained a clear liquid. The pump circulated the clear liquidto simulate blood flow through the cephalic vein. A venous access deviceincluding a hub and a bifurcated cannula was inserted into the centraltube. The hub included a blood sampling channel and a fluid transferchannel. The bifurcated cannula included a blood sampling lumen having ablood sampling port, a fluid transfer lumen having a fluid transferport, and a dividing member separating the blood sampling lumen from thefluid transfer lumen. The blood sampling port was 10 mm proximal fromthe fluid transfer port. A blue dye was introduced to the fluid transferchannel, traveled through the fluid transfer lumen and entered thecentral tube through the fluid transfer port. The circulating liquidexiting the hand was turned blue by the blue dye. A sample of thecirculating liquid was drawn through the blood sampling port and intothe blood sampling channel with a syringe. The sampled circulatingliquid was clear with no trace of blue dye. The simulation confirmedthat the blood sampling port was spaced sufficiently apart from thefluid transfer port to obtain a sample of circulating liquid that wasunaffected by the fluid being transferred.

Example 2—Use in Hospitalized Diabetic Patient (Prophetic)

A fifty-year-old male with type II diabetes goes to a hospital emergencyroom due to chest pains. Once the patient has been admitted, a doctorprescribes intravenous saline and requests that the patient's bloodglucose be tested every 2 hours. A nurse prepares the patient forinsertion of a venous access device having a hub and a bifurcatedcannula. The venous access device will be inserted into the cephalicvein of the patient's left hand. The nurse locates the cephalic vein,applies a tourniquet to the patient's forearm, and swabs the intendedvenous access site with 2% chlorhexidine. A needle is inserted into thepatient's cephalic vein. The bifurcated cannula is advanced over theneedle and into the cephalic vein. The needle is removed and thebifurcated cannula is flushed with 5 mL saline. The hub is attached tothe bifurcated cannula and the tourniquet is removed. An intravenoussaline line is connected to a fluid transfer arm of the venous accessdevice hub and saline is delivered to the patient's cephalic vein. Thenurse attaches a syringe to a blood sampling arm of the venous accessdevice hub and draws a blood sample to test the patient's blood glucose.The nurse returns to obtain additional blood samples every two hours asrequired by the doctor. The patient is able to sleep through the nightsince the nurse is able to obtain blood samples via the venous accessdevice without waking the patient or pricking his finger while hesimultaneously receives intravenous saline.

REFERENCES

1. World Health Organization, “WHO guidelines on drawing blood: bestpractices in phlebotomy”, 2010.

2. “Peripheral venous catheter”, available online aten.wikipedia.org/wiki/Peripheral_venous_catheter, accessed on May 26,2015.

3. “Central venous catheter”, available online aten.wikipedia.org/wiki/Central_venous_catheter, accessed on May 20, 2015.

4. “Peripherally inserted central catheter”, available online aten.wikipedia.org/wiki/Peripherally_inserted_central_catheter, accessedon May 20, 2015.

5. “Intravenous therapy”, available online aten.wikipedia.org/wiki/Intravenous_therapy, accessed on May 20, 2015.

6. Moghissi, E. S. et al., “American Association of ClinicalEndocrinologists and American Diabetes Association consensus statementon inpatient glycemic control”, Endocrine Practice, Vol. 15, No. 4, pp.1-17 (May/June 2009).

7. Adam, K., et al., “Sleep helps healing”, British Medical Journal,Vol. 289, pp. 1400-1401 (November 24, 2984).

8. Magaji, V., et al., “Inpatient management of hyperglycemia anddiabetes”, Clinical Diabetes, Vol. 29, No. 1, pp. 3-9 (2011).

9. Norberg, A., et al., “Contamination rates of blood cultures obtainedby dedicated phlebotomy vs intravenous catheter”, Journal of theAmerican Medical Association, Vol. 289, No. 6, pp. 726-729 (Feb. 12,2003).

10. “Hospital Utilization (in non-Federal short-stay hospitals)”,Centers for Disease Control and Prevention, available online atwww.cdc.gov/nchs/fastats/hospital.htm (May 14, 2015).

11. Shlamovitz, G. Z. et al., “Intravenous Cannulation”, availableonline at emedicine.medscape.com/article/1998177-overview (May 16,2015).

12. “Arrow Twincath® Multiple Lumen Peripheral Catheter Nursing CareGuidelines”, Arrow International, available online atwww.arrowintl.com/documents/pdf/education/tc-ng0803.pdf (downloaded Jul.1, 2015).

What is claimed is:
 1. A venous access device kit, comprising: (a) ahub, comprising, (i) a bifurcated connecting arm, (ii) a blood samplingarm, connected to the bifurcated connecting arm, (iii) a fluid transferarm, connected to the bifurcated connecting arm, (iv) a blood samplingchannel, passing through the blood sampling arm and the bifurcatedconnecting arm, and (v) a fluid transfer channel, passing through thefluid transfer arm and the bifurcated connecting arm, (b) a bifurcatedcannula having an internal dividing member separating a blood samplinglumen from a fluid transfer lumen, coupled to the bifurcated connectingarm, comprising, (i) the blood sampling lumen, having a blood samplingport, and (ii) the fluid transfer lumen, having a fluid transfer port,and (c) a needle, positioned in the fluid transfer lumen, wherein theblood sampling port is 15 mm to 20 mm proximal from the fluid transferport, the bifurcated cannula has a length of 20 to 75 millimeters, thebifurcated cannula is a 17 to 24 gauge cannula, the blood samplingchannel is fluidly connected to the blood sampling lumen, the fluidtransfer channel is fluidly connected to the fluid transfer lumen, thebifurcated cannula is flexible, the bifurcated cannula has a distal endand the distal end is blunt, and the bifurcated cannula and the hub area monolithic component.
 2. The venous access device kit of claim 1,further comprising a fitting coupled to the blood sampling arm.
 3. Thevenous access device kit of claim 1, further comprising a fittingcoupled to the fluid transfer arm.
 4. The venous access device kit ofclaim 1, wherein the bifurcated cannula is a 17, 18 or 19 gauge cannula.5. The venous access device kit of claim 1, wherein the bifurcatedcannula is a 20, 21, 22, 23 or 24 gauge cannula.
 6. The venous accessdevice kit of claim 1, wherein the hub comprises a material selectedfrom the group consisting of polypropylenes, polyethylenes,polycarbonates and polyamides.
 7. The venous access device kit of claim1, wherein the bifurcated cannula comprises a material selected from thegroup consisting of polyurethanes, polyamides, polyether block amides(PEBA) and, polytetrafluoroethylenes (PTFE).
 8. The venous access devicekit of claim 1, wherein the blood sampling port is 18 mm to 20 mmproximal from the fluid transfer port.
 9. The venous access device kitof claim 8, wherein the bifurcated cannula has a length of 50 to 75 mm.10. The venous access device kit of claim 1, wherein the bifurcatedcannula includes only the blood sampling lumen and the fluid transferlumen.
 11. A venous access device, comprising: (a) a hub, comprising,(i) a bifurcated connecting arm, (ii) a blood sampling arm, connected tothe bifurcated connecting arm, (iii) a fluid transfer arm, connected tothe bifurcated connecting arm, (iv) a blood sampling channel, passingthrough the blood sampling arm and the bifurcated connecting arm, and(v) a fluid transfer channel, passing through the fluid transfer arm andthe bifurcated connecting arm, and (b) a bifurcated cannula having aninternal dividing member separating a blood sampling lumen from a fluidtransfer lumen, coupled to the bifurcated connecting arm, comprising,(i) the blood sampling lumen, having a blood sampling port, and (ii) thefluid transfer lumen, having a fluid transfer port, wherein the bloodsampling port is at least 15 mm proximal from the fluid transfer port,the bifurcated cannula has a length of 20 to 75 millimeters, thebifurcated cannula is a 18 to 24 gauge cannula, the blood samplingchannel is fluidly connected to the blood sampling lumen, and the fluidtransfer channel is fluidly connected to the fluid transfer lumen, thebifurcated cannula is flexible, the bifurcated cannula has a distal endand the distal end is blunt, and the bifurcated cannula and the hub area monolithic component.
 12. The venous access device of claim 11,further comprising a fitting coupled to the blood sampling arm.
 13. Thevenous access device of claim 11, further comprising a fitting coupledto the fluid transfer arm.
 14. The venous access device of claim 11,wherein the bifurcated cannula is a 20, 21, 22, 23 or 24 gauge cannula.15. The venous access device of claim 11, wherein the hub comprises amaterial selected from the group consisting of polypropylenes,polyethylenes, polycarbonates and polyamides.
 16. The venous accessdevice of claim 11, wherein the bifurcated cannula comprises a materialselected from the group consisting of polyurethanes, polyamides,polyether block amides (PEBA) and, polytetrafluoroethylenes (PTFE). 17.The venous access device of claim 11, wherein the blood sampling port is18 mm to 20 mm proximal from the fluid transfer port.
 18. The venousaccess device of claim 11, wherein the bifurcated cannula has a lengthof 50 to 75 mm.
 19. The venous access device of claim 11, wherein thebifurcated cannula comprises polyurethane.